ABSTRACT

Few studies have more starkly posed the dilemmas in socially sensitive research than the recent and ongoing clinical trials of medications to treat AIDS. One response to such dilemmas is to include potential participants or surrogates for them in decision making. Although the investigator and relevant regulatory bodies are not absolved of responsibility by community consultation, such a procedure may help to create a partnership between the investigator and participants, consistent with ethical duties of respect for persons, beneficence, and fidelity. Community consultation also may dampen participants’ anxiety and increase perceived justice of decisions about the research. Such a procedure has the potential to mitigate ethical problems in research involving a wide variety of socially sensitive topics and in randomized clinical trials of treatments for conditions other than AIDS.